The patentability of genes is under scrutiny all over the world.

Several weeks ago, the High Court of Australia shed light upon the patentability of nucleic acids (D’Arcy v. Myriad Genetics Inc.). Similar to the situation in the U.S. for 35 U.S.C. §101, the High Court found that an isolated nucleic acid coding for a mutant BRCA1 protein was not patentable subject matter.

Claim 1 of Australian Patent No. 686004 stated:

  1. An isolated nucleic acid coding for a mutant or polymorphic BRCA1 polypeptide, said nucleic acid containing in comparison to the BRCA1 polypeptide encoding sequence set forth in SEQ ID No: 1 one or more mutations or polymorphisms selected from the mutations set forth in Tables 12, 12A, and 14 and the polymorphisms set forth in Tables 18 and 19.

Basically, there are several known mutations of the BRCA1 gene that are linked to breast and ovarian cancers. A biological sample from a patient can be analyzed to see whether his or her nucleic acid sequences match with a known BRCA1 mutant gene sequence, which match suggests an increased risk of breast or ovarian cancer for that patient.

Some highlights of the opinion include the observations that: “Claim 1 covers the gene comprising the nucleic acid sequence as it exists in nature;” “the disputed claims do not say anything about the length of the polynucleotide chains;” and “the class of isolated nucleic acids covered by the claims is very large and diverse.”

The High Court stated that an essential question was whether the subject matter of the claims is sufficiently artificial, or in other words different from nature, to be regarded as patentable. The High Court held that an isolated nucleic acid with specific mutations or polymorphisms was not a “manner of manufacture.”

The debate regarding the patentability of genes in the U.S., Australia, and the rest of the world continues. In the interim, U.S. Applicants can find helpful suggestions as to claiming nucleic acids in 2014 and 2015 Interim Guidance on Subject Matter Eligibility. These tips are especially valuable to those in the fields of Personalized Medicine and Diagnostics.